Studying homeopathy in Third World countries, revisited

I’d like to start this post by thanking a commenter named Paul Grenville. He provided me with this blogging material and, indeed, may have supplied me with material for two blog posts. He did it by showing up in an old post about a homoepath named Jeremy Sherr, who has been bringing woo to the natives, so to speak, by treating HIV/AIDS patients in Africa with homeopathy. Sherr, as you may recall, Sherr had announced his plans to do “clinical trials” using homeopathy for HIV/AIDS and even bragged about treating Tanzanians with quackery. He then tried–shall we say?–to revise history by making the evidence of his claims disappear from the Internet. It worked as well as it always does, as in not very well at all. In any case, this Grenville character apparently has a habit of showing up on old posts critical of homeopathy and whining, and that’s just what he did on my post about Sherr, which is now over a year old, opining:

Homeopathy sceptics have an a priori position on homeopathy, which goes something like this: Homeopathy is “only water” therefore clinical evidence that it works is dismissed out of hand – here’s some evidence. There’s plenty if you look.

Funny, but I sure have looked, and I’ve had a really hard time finding any sort of convincing evidence for the efficacy of homeopathy beyond that of a placebo for any ill. Not that that doesn’t stop apologists like Grenville from believing and trying to get me to believe, too. In any case, Grenville constructs a typical strawman argument beloved of homeopaths. It starts by correctly stating that the position of skeptics like myself is that homeopathy is “only water,” namely because the scientific evidence is overwhelmingly that it is, in fact, just water, at least at dilutions much greater than around 12C. (Many homeopathic dilutions are 20 or 30C.) Indeed, a 30C dilution represents a 1060 dilution, which is roughly 1037-fold greater than Avagadro’s number. In other words, homeopathic remedies tend to be diluted to the point where the odds that a single molecule of the remedy remains is close to nonexistent. Even homeopaths admit this, at least implicitly, coming up with all sorts of woo-ful “explanations,” such as the “memory” of water.

Where the straw man comes in is in the claim that skeptics say that clinical evidence can be “dismissed out of hand.” That’s a mischaracterization of the skeptical position. A better representation would be to say that, given the huge swaths of very well-established science that show that homeopathy can’t work in the way claimed by homoepaths and how physics, chemistry, and biology all conspire to make homeopathy impossible, it would take some incredibly compelling clinical evidence to make us start to question so much established science from so many different scientific disciplines. That’s not to say that, were compelling clinical evidence presented, we wouldn’t start to think about changing our minds. But it would take evidence of a quality and quantity at least in the same order of magnitude of the quality and quantity of evidence supporting the scientific principles and disciplines that say that homeopathy is impossible. Poorly designed clinical trials that show results barely different than a placebo or the occasional well-designed trials that show an effect slightly greater than a placebo but represent a fraction of clinical trials that would be expected to appear positive by random chance alone just don’t cut it. But that’s all homeopaths are ever able to muster.

Still, I’m disturbed by the description of the “trial” that Grenville presents as “evidence” for the efficacy of homeopathy in treating AIDS. This “trial” comes from something called the AIDS Remedy Fund, which is described as the product of two Dutch homeopaths, Jan Scholten, MD and Leo van Gelder, MD, the latter of whom is described as one of the founders of Homeopaths Without Borders and a past chairman of the board. My first thought was that this has to be a joke. Homeopaths Without Borders? As if suffering people in Third World countries don’t have enough problems without having to worry about a bunch of quacks descending upon them. And–oh, goody!–HWB is looking to help out Haiti! I’m sure that’ll work out real well. Besides, Haiti already has plenty of its own “natural healers” pushing unscientific remedies. It doesn’t need to import more. What it needs are real doctors, real nurses, and scientific medicine. Donate to Doctors Without Borders or the American Red Cross instead.

The aim of the Aids Remedy Fund (ARF) foundation is to study the effectiveness of homeopathic therapy for HIV/Aids and to make the remedy available at low cost to large populations suffering from the disease. The foundation is non-profit.

The foundation has successfully undertaken a pilot study of the effectiveness of the drug Iquilai to combat the effects of HIV/Aids within an HIV-infected population in Kenya. The most significant result of this pilot is that more than 90% of the patients showed improvement in their health.

So what is Iquilai? According to the website, this:

Homeopathic medicines are prepared in a way that is known as potentiation. In this, the medicinal action of the base ingredients (animal, vegetable and min- eral) is transferred to a substance from which the medications are composed.

Jan Scholten, a doctor based in Utrecht, The Netherlands, has developed a new homeopathic drug. The active ingredient is one of the mineral based substances. His goal was the development of a therapy for the treatment of HIV/Aids aimed at the restoration of the patient’s damaged immune system.

Potentiation (or potentization, as I’ve sometimes seen it called) is the process of vigorously shaking or “succussing” the homeopathic remedy at each dilution step. It is this succussion, homeopaths will oh-so-seriously tell you with a condescending tone in their voice not unlike that of an adult correcting a particularly dumb child, that supposedly imbues the homeopathic remedy with its potency. In other words, it’s the shaking that makes the magic water magical.

As for Iquilai itself? A news story describes it thusly:

“The Iquilai is a potentised natural remedy. It has been found to be effective in the treatment of HIV and Aids since it restores the balance of minerals,” said Ombaka.

Gelder explained that the mineral balancing was essential to ensure there is no lack or abundance of vital minerals in the body.

“Mineral imbalances are inter- connected with imbalances in the immune system and this helps to reduce insufficiency of the immune system, which is Aids,” Gelder explained.

Restoring the balance in the mineral content goes together with the balancing of the mental and emotional state.

The remedy, the researchers disclosed, focused on returning the body to its natural state of balance.

This is, of course, utter nonsense. The pathogenesis of HIV/AIDS has nothing to do with a “lack or abundance of vital minerals in the body” and everything to do with HIV attacking T-helper cells and over several years obliterating them to the point that severe immunodeficiency occurs. Even if Iquilai could “restore vital minerals,” it would do nothing for HIV or to slow the progression of HIV infection to AIDS. I also note that Gelder appears to be engaging in a bit of HIV/AIDS denialism in that he doesn’t even mention the virus. Of course, this is not surprising, because homeopathy is a pre-germ theory philosophy. It does not sit well in the 21st century. Now, here’s a description of the “study,” which looked at 250 people in Kenya, and its findings:

Patients were given the opportunity to be treated with the homeopathic drug. This took place within the existing ‘home based care’ programme run by the Kenyan doctor James Ombaka, a dermatologist and microbiologist at the Ganjoni Hospital in Mombassa. The patient population comprised both patients under ARV treatment and patients who were not undergoing any ARV therapy. The greater part of the patients was in an advanced stage of Aids (stages 3 and 4 according to the WHO classification).

Following a positive HIV test at the start of the treatment, the patients received a dose of the drug once a day for five days. Where there was deterioration in health, a further dose was given (currently this last prescription was adapted to one granule once a month for five months).

The results were described as follows:

Within two weeks, an improvement in appetite and an increase in energy and weight could be observed. In addition, in more than 90 percent of the patients recovery from opportunistic infections, such as the disappearance of diarrhoea, respiratory infections and skin problems was seen.

This applied to both patients treated with conventional drugs and the group not receiving any ARV treatment.

The CD4 tests, which had initial values under 200, showed significant improve- ment. The levels increased by an average of 123 points (a CD4 value of 200 or less is a critical lower limit for which anti-viral therapy is deemed necessary).

An improvement in quality of life could be observed in the whole research group. Restoration of independent functioning became possible for practically the whole population after treatment with Iquilai.

Can anyone tell me why this is at best a highly dubious study? Try not to read on for a minute and think why. Then see if your answer agrees with mine. Also remember that, if the homeopaths were correct and their nostrums actually did produce major clinical improvements for 90% of HIV/AIDS patients and their methodology was sound, they could easily publish this study in a real medical journal (as opposed to fake medical journals like homeopathy journals). Yet they haven’t. I wonder why?

So why is this “study” so questionable? Let me count the ways. First, it included patients on and off antiretroviral therapy. That in and of itself wouldn’t necessarily be a problem for a pilot project, but nowhere is it adequately described how many patients taking ARV improved on Iliquai compared to how many not taking ARV. More importantly, there is no control group. We have no idea if the number of patients who improved is typical for any patient with HIV or AIDS who simply undergoes routine care for HIV/AIDS, even in Kenya. In fact, when it comes to the quality of life measurements, this study design is almost guaranteed to produce apparent “improvements” just based on the fact that the people doing the measurements know that every person they evaluate periodically is taking the remedy being studied. As for the alleged improvement in an objective measure, namely CD4 cell count, which was claimed to have improved significantly, it turns out that if you read the study you’ll find that only 51 out of the 228 patients had serial CD4 counts drawn at three intervals and 85 at two intervals. That’s only a little more than half of the patients enrolled on the study. No reasons are given for why so many patients didn’t have more than one CD4 counts drawn; we have no idea what happened to their CD4 counts; and no description is given to show whether the group that did get more than CD4 level drawn was the same as the group that did not. Moreover, if you look at the table on page 17, you’ll see that the values are 161 Â± 93 at the beginning and 284 Â± 126 at the end, a rather large overlap that is claimed to be very statistically significant. Maybe so, but again without a control group and not knowing what happened with nearly half the patients I remain underwhelmed. This is not the sort of highly compelling data that would lead me to start to question huge swaths of established science. Extraordinary claims require extraordinary (or at least copious amounts of) evidence, and this study doesn’t qualify.

Regardless of the results, without a control group, there is nothing there to provide convincing support to claims made in the report that HIV/AIDS could be treated with a short course of Iquilai; that treatment with the homeopathic magic water can delay the need for ARV therapy; or that there could be “no resistance” to the Iquilai because it “fights the virus causing the illness from the inside out.” If prior probability is taken into account, then there’s really nothing here, at least nothing compelling enough to convince me that homeopathy is more than water.

In fact, there is only one statement in this report that I can mostly agree with, and that’s this:

The drug has not exhibited any side effects so far and their occurrence is not likely. This is a characteristic of all homeopathically prepared medications. The reason for this is that the original substance has been potentiated, which means that it has been shaken and diluted in stages so that no further chemical reactions can occur.

I agree. Homeopathic remedies do not exhibit any side effects because they are nothing more than magic water, and this is indeed a characteristic of all homeopathic remedies. No “further chemical reactions” can occur because there’s no chemical from the original remedy left, only water! Indeed, hilarious confirmation of this comes from the description in the report that points out that Iquilai can’t be patented because the “present state of technology is not yet able to determine whether a homeopathic drug is authentic or not.”

Comedy gold!

What’s not funny, though, as I’ve described before discussing a trial of homeopathy for childhood diarrhea in Honduras, is that trials of this type are profoundly unethical. Given that homeopathy is water (heck, they even admit it in the “study report” with their pointing out that none of substance remains and they can’t patent it because a homeopathic remedy can’t be distinguished from water), offering homeopathy to patients with a life-threatening disease violates the Helsinki Declaration. If a study must be done, then to be in accordance with the principles of the Helsinki declaration all subjects in the trial must receive the current standard of care, namely ARV therapy. Then, for scientific rigor, it must be randomized and double blinded with rigorous matching of control groups. My guess is that such a trial would very likely be negative. It would also be a colossal waste of time, although because the Helsinki Declaration demands that no human subject in a research trial get less than the standard of care without an incredibly good reason to justify otherwise some Africans might get ARV who otherwise might not get it.

Idiocy like this “study” by the AIDS Remedy Fund really burns me. HIV/AIDS in Africa is a huge problem that has resulted in some horrific abuses from various pseudoscientists, be they quacks like Matthias Rath claiming he can treat AIDS with vitamins or deluded homeopaths. (Is that a redundant statement?) In any case, it doesn’t help to have deluded Westerners arrive from their comfortable existences thinking that they are doing good when in fact they are doing nothing more than bringing fairy dust with them and then publishing dubious reports rather than publishing their work in the peer-reviewed literature, where scientists can evaluate the full study design and analysis. And, no, homeopathy journals or “alternative medicine” journals, which are prone to publishing the rankest pseudoscience, don’t cut it. If the results are as compelling as the AIDS Remedy Fund claims, then it should try to get it published in a real journal. That in and of itself would not be enough to overturn so much established science (at minimum, multiple replications from other groups in other populations would be required and a mechanism by which the homeopathic remedy works would also be good to know–at least a hint of a real, nonmagical mechanism), but it would at least allow us to see if these seemingly fantastic results stand up to closer scrutiny.

35 Comments

Ugh. So far, I’ve seen nothing good come from purveyors of “alternative” anything vis a vis the African nations in need of outside help.

I find that most of the Alt-types talking about “Africa” fail to think of Egypt and South Africa as in Africa at all, preferring, I think, to see the continent as one giant desert country full of starving infected primitive tribes. It’s more romantic that way, after all, and they can then think of themselves as saviours riding in on their white steeds to save the day, instead of quacks forcing non-medicine on people who desperately need real help instead of being taken advatage of by profit-mongering assholes.

In Kenya, there is some official recognition of traditional medicine, but no regulation. There have been calls for regulation. And there is no specific mention of homeopathy. However, the fact that there is no explicit regulation of homeopathy does not mean that homeopaths can act with a free hand.

Kenya has regulations regarding medical trials – in particular “Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya” issued by the National Council for Science and Technology. Do not be fooled by the word “Guidelines” – compliance is mandatory and the document has legal power.

This document raises a lot of issues about the trial but one thing in particular caught my attention.

“Externally Sponsored Research

Externally sponsored research entails two ethical obligations.

An external sponsoring agency should submit the research protocol to ethical and scientific review according to the standards of the country of the sponsoring agency, and the ethical standards applied should be no less exacting than they would be in the case of research carried out in that country.

After scientific and ethical approval in the country of the sponsoring agency, the appropriate ethical clearance committee of the institution in Kenya where the research is to be conducted must satisfy themselves also that the proposed research meets the established scientific and ethical requirements.”

I have contacted the ARF requesting information on which body they received scientific and ethical approval from. So far, I have received no response. I have contacted Jan Scholten via his website. No response.

The Centrale Commissie Mensgebonden Onderzoek (CCMO) maintain a voluntary register of trials. However, it is voluntary. They have no record of the ARF applying for ethical review to any of the relevant bodies in the Netherlands.

I have contacted the Kenyan authorities, but they have not responded to me. This was several months ago.

I do have some more information, but I’m not sure that people will be that interested…

I’ve been covering this stuff for years on my blog. Like warhelmet I contacted various authorities and exposed various lies but it just rumbles on. I’ve been trying to get homeopaths to deal with all the issues this raises and I have failed so far.

The remedy restores minerals. Okaaaaay . . . so how does that even gibe with homeopathic principles? That goes against the Law of Similars. If the remedy actually does treat AIDS (and I notice he made no attempt to prove that it does, instead merely asking us to take his word that it does), then shouldn’t a homeopathic preparation of it be good for, say, treating autoimmune disorders and other conditions where the immune system is overreacting?

If they can’t even be internally consistent, why are homeopaths so surprised that we treat them with contempt? (That’s a rhetorical question; I know the answer. Because they are either charlatans or don’t grasp the concept of curiosity.)

Homeopaths in Haiti ? Perhaps not to bad as it sounds. I mean, Haitians are so starved that they sometimes have to eat clay cakes in order to be relieved from the torture of an empty stomach. Sugar pills are always better than clay. Just make sure they bring lots, lots of sugar pills.

You (and others) might be interested to know that the requirement to conduct trials to the same ethical standard as your own country is actually enshrined within the 4th revision of the Declaration of Helsinki, which has not been ratified by the US as they did not want to be bound by this clause.

This does not affect this case as the EU (and therefore Holland) have ratified this revision, but it does illustrate that there isn’t a clear ethical position worldwide.

Of course the basic premise that you cannot withhold treatment from subjects for magic water is still the major sticking point, and one that I think is covered by the declaration of Nuremberg- which is the first of the international clinical trial conduct agreements.

“I find that most of the Alt-types talking about “Africa” fail to think of Egypt and South Africa as in Africa at all, preferring, I think, to see the continent as one giant desert country full of starving infected primitive tribes. It’s more romantic that way, after all, and they can then think of themselves as saviours riding in on their white steeds to save the day, instead of quacks forcing non-medicine on people who desperately need real help instead of being taken advatage of by profit-mongering assholes.”

You know, this whole thing would be a laugh-fest were it not for the fact that too many people will buy into the homeopathic bulloney and refuse medication. And thus, die.
This “Dr” Scherr or whatever his name is should be locked up for attempted murder, or even negligent homicide if people die unnecessarily due to his quackery.

Why can’t the Homeopaths treat something like toe fungus as a test trial? We have that new drug for treating it so they can compare the homeopathic result to non-treatment to the EB treatment. Also, the ethical issues are much more manageble than with HIV/Aids.

“…offering homeopathy to patients with a life-threatening disease violates the Helsinki Declaration.”

In the case of the Honduran diarrhea study, they could get around this requirement by adding one teaspoon of salt and eight teaspoons of sugar to each liter of homeopathic solution and comparing this to the same mixture made with “regular” (but boiled or otherwise disinfected) water. [Note: this is the WHO rehydration solution recipe]

In all studies of homeopathy that use placebo control, the efficacy of the homeopathic remedies hover near the eeficacy of the placebo. This should tell people all they need to know – homeopathy is a placebo! Even the most “favorable” studies of homeopathy (which invariably have no controls and/or blinding) fail to show the dramatic results the homeopaths promise.

The only promise of homeopathy that has been fulfilled is the lack of side effects, unless you count delay or failure to get timely real treatment as a “side effect”.

@Prometheus | January 19, 2010 2:05 PM “The only promise of homeopathy that has been fulfilled is the lack of side effects, unless you count delay or failure to get timely real treatment as a “side effect”.”

Apparently a British homeopathy sceptics group, 1023 is protesting Boots selling homeopathic remedies on Jan 30th (see link on my name). Perhaps it’d be worth expanding this to protesting about this sort of thing? (I’m thinking of in case the get some decent publicity.) Loose thought, etc.

i have commented about the “home based care programme” as a possible explanation as to why people improved on gimpys blog. i would retype it all again but i am so lazy but it is worth a look i hope. but this PDF explains what the home based care programme is:

The legal status of homoeopathy in India is on an equal footing with both conventional and Ayurvedic medicine.

Regular full time medical degree for a minimum period of 5 1/2 years (BHMS) that includes one year compulsory internship, is absolutely necessary for becoming qualified to practice homeopathy in India as it gives a complete understanding not only about the structure and functioning of the human body but also a thorough understanding of the homeopathic philosophy and its practical utilization while treating diseased persons.

And to do M.D. in homeopathy further, admission is through an entrance examination, and you have to spend three more years after BHMS.

Malik even showed up to comment on my virtually unread blog regarding my Homeopathy is Full of Shit posters. I get keeping an eye on the big dogs, but going after blogs when you see that there are hardly any followers or comments? Desperate and needy are words that spring to mind.

Even homeopaths admit this, at least implicitly, coming up with all sorts of woo-ful “explanations,” such as the “memory” of water.

Which doesn’t work, because if all molecules of the active substance are pretty much gone at C12, all water molecules that could conceivably have remembered being in contact with the active substance will be gone by C24.

She has a profile up on the Museum of Hoaxes website (how apt). She’s another example of the problem of altie practitioners foisting useless treatments on the poor who are in desperate need of real medicine. From her profile:

“She renders service to the poor by organising medical camps through Helping hand trust, a non-governmental voluntary organization working at grass root level in the field of Health.”

Ya I am totally agree that We should not depend on only homeopathy! It is not totally solution. But it is also true that homeopathy will help to prevent some disease also. Thank you for sharing a good article with us.